Attach 13 Survey Question Sources & Relevance

Attach 13 Survey Question Sources & Relevance.docx

Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation

Attach 13 Survey Question Sources & Relevance

OMB: 0923-0046

Document [docx]
Download: docx | pdf

Attachment 13: Survey Question Sources & Relevance


ENROLLMENT SURVEY FOR MOTHERS


Questionnaire Section

Question Numbers

Source of Questions

Reference

Revision

Used to Measure

Relevance of Information Obtained

Record of Consent

N/A

Navajo Birth Cohort Study

None

New

Record of Informed Consent

Administrative use

Introduction/Contact Information

N/A

Navajo Birth Cohort Study

None

New

Eligibility, contact information

Administrative use

Father Participation

N/A

Navajo Birth Cohort Study

None

New

Willingness to contact baby's father

Administrative use ; Fathers play an important role in exposure assessment for epigenetics and occupational/home history that could affect outcomes in the baby

Demographics

Q1-Q13

Tar Creek project (Ettinger)

None

Q3 added about language preferences; Q11 revised from N.American to Navajo

Demographic factors

Potential confounders or effect modifiers of relationships of interest: age, birthplace, race, socioeconomic status, education

Reproductive History

Q14-Q28

Tar Creek project (Ettinger)

None

Q24 revised to include NAIHS facilities

Reproductive history

Previous reproductive history important covariate when assessing reproductive, birth, and developmental outcomes; Past history of miscarriages, birth control use, breastfeeding, fecundity, parity serves as important covariate information when assessing reproductive and birth outcomes.

Current Pregnancy Information

Q29-Q36

Tar Creek project (Ettinger)

None

Not Changed

Current pregnancy information

Potential confounders or effect modifiers of relationships of interest; Prenatal care, breast feeding, and multiplicity of birth have been associated with birth and reproductive health outcomes.

Current Medications/ Substances

Q37-Q46

Tar Creek project (Ettinger)

None

Not Changed

Use of medications and substances

Potential confounders or effect modifiers of relationships of interest; Certain medications and well as substance abuse may contribute to adverse birth outcomes.

Alcohol Use

Q47-Q49

Tar Creek project (Ettinger)

None

Not Changed

Use of alcohol

Potential confounders or effect modifiers of relationships of interest; Alcohol use during pregnancy has been associated with adverse birth outcomes.

Tobacco Use

Q50-Q59

Tar Creek project (Ettinger)

None

Not Changed

Use of tobacco

Potential confounders or effect modifiers of relationships of interest; Tobacco use during pregnancy has been associated with adverse birth outcomes.

Stress

Q60-Q65

Kessler Psychological Distress Scale 6-item (K6)

Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in nonspecific psychological distress. Psychological Medicine 2002; 32: 959-976. (see Table 2 for specific questions)

Not Changed

A 6-question screening scale of psychological distress embedded within the 10-question scale were developed for the redesigned US National Health Interview Survey (NHIS). 6 questions evaluate: depressed mood, agitation, fatigue, guilt/worthlessness, and anxiety.

Potential confounders or effect modifiers of relationships of interest; Stress during pregnancy has been linked to adverse health fetal outcomes as well as vulnerability to certain chemical toxins.

Physical Activity

Q66-Q68

Navajo Birth Cohort Study

None

New

Physical activity

Potential confounders or effect modifiers of relationships of interest; Normal BMI and physical activity have been associated with better birth outcomes.

Housing Characteristics

Q69-Q87

DiNEH Project

None

Not Changed

Housing characteristics (exposures)

Potential exposure sources; Water damage, mold, mildew, livestock, presence of pets, and coal wood burning in the home may be important covariates. Questions complement environemntal home assessment testing.

Water Usage

Q88-Q92

DiNEH Project

None

Not Changed

Water usage exposures

Potential exposure sources; As indicated in the DiNEH project and CDC water hauling study, unregulated water sources may be contaminated with uranium or other heavy metals. These survey questions will complement the water testing in the home assessment.

Food Behaviors

Q93-Q99

DiNEH Project

None

Not Changed

Livestock and gardening exposures

Potential exposure sources

Occupational/Environmental

Q100-Q115

DiNEH Project

None

Not Changed

Occupational and environmental exposures

Potential exposure sources



ENROLLMENT SURVEY FOR FATHERS


Questionnaire Section

Question Numbers

Source of Questions

Reference

Revision

Used to Measure

Relevance of Information Obtained

Contact Information

N/A

Navajo Birth Cohort Study

None

New

Contact information

Administrative use

Demographics

Q1-Q9

Tar Creek project (Ettinger)

None

Q3 added about language preferences; Q15 new question added

Demographic factors

Potential confounders or effect modifiers of relationships of interest: age, birthplace, race, socioeconomic status, education

Health History

Q10-Q15

Tar Creek project (Ettinger)

None

Not Changed

Health history

Potential confounders or effect modifiers of relationships of interest

Current Medications/ Substances

Q16-Q22

Tar Creek project (Ettinger)

None

Not Changed

Use of medications and substances

Potential confounders or effect modifiers of relationships of interest

Alcohol Use

Q23-Q25

Tar Creek project (Ettinger)

None

Not Changed

Use of alcohol

Potential confounders or effect modifiers of relationships of interest

Tobacco Use

Q26-Q35

Tar Creek project (Ettinger)

None

Not Changed

Use of tobacco

Potential confounders or effect modifiers of relationships of interest

Stress

Q36-Q41

Kessler Psychological Distress Scale 6-item (K6)

Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in nonspecific psychological distress. Psychological Medicine 2002; 32: 959-976. (see Table 2 for specific questions)

Not Changed

A 6-question screening scale of psychological distress embedded within the 10-question scale were developed for the redesigned US National Health Interview Survey (NHIS). 6 questions evaluate: depressed mood, agitation, fatigue, guilt/worthlessness, and anxiety.

Potential confounders or effect modifiers of relationships of interest

Physical Activity

Q42-Q44

Navajo Birth Cohort Study

None

New

Physical activity

Potential confounders or effect modifiers of relationships of interest

Housing Characteristics

Q45-Q63

DiNEH Project

None

Not Changed

Housing characteristics (exposures)

Potential exposure sources

Water Usage

Q64-Q68

DiNEH Project

None

Not Changed

Water usage exposures

Potential exposure sources

Food Behaviors

Q69-Q74

DiNEH Project

None

Not Changed

Livestock and gardening exposures

Potential exposure sources

Occupational/Environmental

Q75-Q90

DiNEH Project

None

Not Changed

Occupational and environmental exposures

Potential exposure sources



















POSTPARTUM SURVEY (2 MONTHS)


Questionnaire Section

Question Numbers

Source of Questions

Reference

Revision

Used to Measure

Relevance of Information Obtained

Contact Information

N/A

Navajo Birth Cohort Study

None

New

Updated contact information

Administrative use

Birth Information

Q1-Q2

Tar Creek project (Ettinger)

None

Q1 revised to include NAIHS facilities

Birth information

Potential confounders or effect modifiers of relationships of interest: age, birthplace

Breastfeeding

Q3-Q5

Tar Creek project (Ettinger)

None

Not Changed

Breastfeeding practices

Potential exposure sources

Infant Formula Preparation

Q7-Q8

Tar Creek project (Ettinger)

None

Not Changed

Use and preparation of infant formula

Potential exposure sources

Cessation of Breastfeeding

Q9-Q10

Tar Creek project (Ettinger)

None

Not Changed

Cessation of breastfeeding

Potential exposure sources

Pregnancy/Delivery Medical History

Q11-Q23

Tar Creek project (Ettinger)

None

Not Changed

Common adverse events in pregnancy/delivery

Potential confounders or effect modifiers of relationships of interest

Current Medications/ Substances

Q24-Q32

Tar Creek project (Ettinger)

None

Not Changed

Use of medications and substances

Potential confounders or effect modifiers of relationships of interest

Alcohol Use

Q33-Q35

Tar Creek project (Ettinger)

None

Not Changed

Use of alcohol

Potential confounders or effect modifiers of relationships of interest

Tobacco Use

Q36-Q45

Tar Creek project (Ettinger)

None

Not Changed

Use of tobacco

Potential confounders or effect modifiers of relationships of interest

Postnatal Depression

Q46-Q55

Edinburgh Postnatal Depression Scale (EPDS)

Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression: Development of the 10-item Edinburgh Postnatal Depression Scale. British Journal of Psychiatry 1987; 150:782-786.

Not Changed

A widely used screening tool for postpartum depression which has been adapted and validated in many languages. The 10-item EPDS questionnaire was developed to identify women who have postpartum depression and may be used up to 8 weeks postpartum and can also be applied for depression screening during pregnancy.

Potential confounders or effect modifiers of relationships of interest

Housing Characteristics

Q50-Q67**

DiNEH Project

None

Not Changed

Housing characteristics (exposures)

Potential exposure sources

Water Usage

Q68-Q72**

DiNEH Project

None

Not Changed

Water usage exposures

Potential exposure sources

**Note: these questions are misnumbered and should start with Q56




















POSTPARTUM SURVEY (6,9, 12 MONTHS)


Questionnaire Section

Question Numbers

Source of Questions

Reference

Revision

Used to Measure

Relevance of Information Obtained

Contact Information

N/A

Navajo Birth Cohort Study

None

New

Updated contact information

Administrative use

Current Breastfeeding

Q1-Q2

Tar Creek project (Ettinger)

None

Not Changed

Current breastfeeding practices

Potential exposure sources

Infant Formula

Q3-Q4

Tar Creek project (Ettinger)

None

Not Changed

Use and preparation of infant formula

Potential exposure sources

Cessation of Breastfeeding

Q5

Tar Creek project (Ettinger)

None

Not Changed

Cessation of breastfeeding

Potential exposure sources

Introduction of Foods

Q6-Q9

Tar Creek project (Ettinger)

None

Not Changed

Introduction of foods

Potential exposure sources

Foods Sources (WIC)

Q10

Tar Creek project (Ettinger)

None

Not Changed

Use of WIC program services

Potential confounders or effect modifiers of relationships of interest

Home Questions and Observations

Q11-Q28

Home Observation for Measurement of the Environment (HOME) Inventory Scale

Caldwell BM, Bradley R. Home Observation for Measurement of the Environment. University of Arkansas, Little Rock, 1979. Additional references available here: http://fhdri.clas.asu.edu/home/references.html

Not Changed

Designed to measure the quality and quantity of stimulation and support available to a child in the home environment. Infant/Toddler (IT) HOME is designed for use during infancy (birth to age three). These questions are designed for children up to age 12 months.

Potential confounders or effect modifiers of relationships of interest

Perceived Stress Scale

Q29-Q32

Perceived Stress Scale 4-item scale (PSS-4)

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of Health and Social Behavior 1983; 24: 386-396. More information available at: http://www.ncsu.edu/assessment/resources/perceived_stress_scale.pdf

Not Changed

Most widely used psychological instrument for measuring perception of stress. The PPS includes 10 questions (PSS-10), but a short 4-item scale (PSS-4) can be made from questions #2,4,5, and 10 of the PPS-10.

Potential confounders or effect modifiers of relationships of interest
















NUTRITION SURVEYS

Questionnaire Name/ Section

Question Numbers

Source of Questions

Reference

Revision

Used to Measure

Relevance of Information Obtained

Food Frequency Questionnaire**

N/A

Original Source: Harvard Nurses' Health Study and Health Professionals' Study. Revised and validated for use in Native American, low-income, and pregnant women.

1: Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985 Jul;122(1):51-65. 2: Wei EK, Gardner J, Field AE, Rosner BA, Colditz GA, Suitor CW. Validity of a food frequency questionnaire in assessing nutrient intakes of low-income pregnant women. Matern Child Health J. 1999 Dec;3(4):241-6. 3: Baer HJ, Blum RE, Rockett HR, Leppert J, Gardner JD, Suitor CW, Colditz GA. Use of a food frequency questionnaire in American Indian and Caucasian pregnant women: a validation study. BMC Public Health. 2005 Dec 15;5:135. 4: Watts V, Rockett H, Baer H, Leppert J, Colditz G. Assessing diet quality in a population of low-income pregnant women: a comparison between Native Americans and whites. Matern Child Health J. 2007 Mar;11(2):127-36.

See details below

Nutritional intake from diet will be assessed using a semi-quantitative food-frequency questionnaire based on the methods of Willet et al. and validated in Native American populations (Watts et al. 2007). Dr. Ettinger has extensive experience in nutritional assessment in Native populations living near the Tar Creek Superfund Site where this questionnaire was using successfully to establish maternal dietary patterns and nutrient intake during pregnancy and the relationships to environmental exposures. Navajo Team members have provided supplemental input to the questionnaire based on traditional diets and the UNM-CTSA nutritionists have developed nutritional equivalents for those foods.

Potential confounders or effect modifiers of relationships of interest

Dairy

Q1-Q8

Tar Creek project (Ettinger)

Same as above

Not changed

Same as above

Potential confounders or effect modifiers of relationships of interest

Fruits

Q9-Q15

Tar Creek project (Ettinger)

Same as above

Not Changed

Same as above

Potential confounders or effect modifiers of relationships of interest

Vegetables

Q16-Q28

Tar Creek project (Ettinger)

Same as above

Added Q28 "wild spinach or other native (wild) plants"

Same as above

Potential confounders or effect modifiers of relationships of interest

Meat and Fish

Q29-Q39

Tar Creek project (Ettinger)

Same as above

Added "corn dog" to Q33; "Navajo burger" to Q36; revised Q37 and Q38 to include "lamb (mutton)"

Same as above

Potential confounders or effect modifiers of relationships of interest

Sweets, Cereals, Baked Goods

Q40-Q50

Tar Creek project (Ettinger)

Same as above

Added Q50 "tortilla"

Same as above

Potential confounders or effect modifiers of relationships of interest

Other Foods

Q51-Q61

Tar Creek project (Ettinger)

Same as above

Added Q51 "Navajo taco"; Q52 "frybread"; Q53 "blue corn mush"

Same as above

Potential confounders or effect modifiers of relationships of interest

Beverages

Q62-Q69

Tar Creek project (Ettinger)

Same as above

Not changed

Same as above

Potential confounders or effect modifiers of relationships of interest

Other Eating Habits

Q70-Q84

Tar Creek project (Ettinger)

Same as above

Added Q73 "prenatal vitamins"; Q74 "type of prenatal vitamins"; revised Q77 to include "lamb (mutton)"

Same as above

Potential confounders or effect modifiers of relationships of interest

** Note: FFQ included in IRB/OMB packet has been revised based on extensive consultations with Navajo Team members about Navajo-specific foods






Potential confounders or effect modifiers of relationships of interest

Questionnaire Name/ Section

Question Numbers

Source of Questions

Reference

Revision

Used to Measure

Relevance of Information Obtained

WIC Women's Nutrition Questionnaire

Arizona Department of Health Services

http://www.azdhs.gov/azwic/

Not Changed

WIC nutritional assessments are general screening tools and not used for research purposes. The study team will consult with Navajo WIC program as needed.

Potential confounders or effect modifiers of relationships of interest

Energy and Nutrients

Q1-Q6

Arizona WIC Program

http://www.azdhs.gov/azwic/

Not Changed

Will consult with WIC programs as needed

Potential confounders or effect modifiers of relationships of interest

Food Groups

Q1-Q8

Arizona WIC Program

http://www.azdhs.gov/azwic/

Not Changed

Will consult with WIC programs as needed

Potential confounders or effect modifiers


12


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorHunter, Candis (ATSDR/DTHHS/EEB)
File Modified0000-00-00
File Created2021-01-29

© 2024 OMB.report | Privacy Policy